Investigation of the Effects of Aerobic and Resistance Exercise Training in Individuals With Gastrointestinal Cancer and Cachexia: Randomized Controlled Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluation of Demographic and Clinical Information
研究概览
简要总结
This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.
A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.
Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:
Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.
The exercise group will participate in a supervised and home-based exercise program consisting of aerobic and resistance exercises over 12 weeks.
The intensity will be progressively adjusted based on the individual's perceived exertion.
详细描述
Cancer cachexia is a multifactorial syndrome characterized by progressive functional impairment and loss of skeletal muscle mass, which does not improve with nutritional support. This study aims to evaluate the effects of a 12-week aerobic and resistance exercise program in cancer patients with cachexia compared to standard care.
A total of 40 participants aged 18 to 65, diagnosed with gastrointestinal cancer and cachexia, will be included in the study. Participants will be randomly assigned to the exercise group (aerobic and resistance training) or the control group (standard care), with 20 individuals in each group.
The study will be single-blind, meaning the outcome assessor will not know which group the participants belong to.
Before the 12-week intervention, both the exercise and control groups will undergo evaluations. Demographic and clinical data will be recorded. The following assessments will be conducted:
Body Composition: Bioelectrical impedance analysis Sarcopenia Assessment: SARC-F questionnaire Functional Exercise Capacity: 6-minute walk test Gait Parameters: 8-meter walk test Mobility and Balance: Timed Up and Go test Muscle Strength: Knee extensor and hand grip strength measured with dynamometers 30-second sit-to-stand test Additionally, participants will complete several questionnaires, including the Edmonton Symptom Assessment Scale, Karnofsky Performance Status scale, FRAIL scale, Fatigue Severity Scale, and EORTC-QLQ30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be single-blind, meaning that the Outcomes Assessor and the researcher implementing the exercise program will be different individuals. The Outcomes Assessor will not be aware of which group the participants belong to.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III-IV gastrointestinal cancer diagnosis
- •Age ≥ 18 years
- •Receiving systemic treatment (chemotherapy and/or targeted therapy and/or immunotherapy), at least 6 weeks after surgery,
- •Karnofsky performance score 80 and above,
- •Diagnosis of cachexia according to diagnostic criteria and Glasgow Prognostic Score (5,30) (>5% weight loss in the last 6 months or >2% weight loss in patients with BMI less than 20 kg/m2 or >2% weight loss in sarcopenic individuals)
排除标准
- •Musculoskeletal disorder
- •Neurological disorder
- •Severely impaired hematological capacity
- •History of cardiac disease
- •Uncontrolled hypertension
- •Severe renal insufficiency
- •Advanced osteoporosis
- •Decreased ability to stand or walk
结局指标
主要结局
Evaluation of Demographic and Clinical Information
时间窗: At baseline and after 12 weeks of exercise training
Age, gender, occupation, education status, marital status, medical history, family medical history, medications used, smoking and exercise habits, clinical information about cancer (diagnosis date, cancer stage, treatment received, and treatment start and end times) will be recorded.
Weight Assessment
时间窗: At baseline and after 12 weeks of exercise training
Weight change in a certain period and percentage of initial weight are used to determine weight loss. Weight loss of 5%, 10% or 20% in a certain period is associated with an increased risk of malnutrition. The participants' weights will be recorded in kilograms.
Height Assessment
时间窗: At baseline and after 12 weeks of exercise training
The participants' heights will be recorded in centimeters.
Body Mass Index Assessment Body Mass Index Assessment
时间窗: At baseline and after 12 weeks of exercise training
The participants' Body Mass Index (BMI) values will be recorded in kg/m² (kilograms per square meter).
Assessment of Muscle Strength
时间窗: At baseline and after 12 weeks of exercise training
Quadriceps femoris muscle strength will be evaluated using a digital dynamometer (Lafayette, USA). The tests will be performed in the sitting position. Muscle strength will be tested in the middle of the joint range of motion, and the maximum isometric contraction will be measured for 5 seconds. The muscle strength measurement will be repeated 3 times on the right and left sides, and the best value obtained will be recorded in kilograms (kg). Hand grip strength will be measured with a hydraulic dynamometer (Jamar, Sammons Preston Rolyan, Chicago, USA). The test will be performed while patients are sitting comfortably with the shoulder adducted, the forearm neutrally rotated, the elbow flexed 90° and the forearm and wrist in a neutral position. Patients will be instructed to perform a maximum isometric contraction. The participants' hand grip strengths will be recorded in kilograms.
Assessment of Lower Extremity Performance
时间窗: At baseline and after 12 weeks of exercise training
Lower extremity performance will be evaluated with a 30-second sit-to-stand test, in which the number of times a person can sit down and stand up in 30 seconds is recorded.
Sarcopenia Assessments
时间窗: At baseline and after 12 weeks of exercise training
The steps determined by ESWGOP will be followed in sarcopenia screening. The 5-question SARC-F questionnaire is a rapid screening questionnaire used in sarcopenia assessment. Responses are scored between 0-2 and the total score is between 0-10. A total score of 4 or more indicates the presence of a risk for sarcopenia.
Assessment of Muscle and Fat Mass
时间窗: At baseline and after 12 weeks of exercise training
Bioelectrical impedance analysis (Inbody 720) will be used for muscle and fat mass assessment. Participants' muscle and fat mass will be recorded in kilograms.
Mobility, balance and performance assessment
时间窗: At baseline and after 12 weeks of exercise training
For mobility, balance and performance assessment; Timed Up and Go test (TUG) will be used. TUG will be performed by standing up from a chair (sitting height 46 cm), walking 3 m to a line marked on the floor, crossing the line, turning around and walking back, and sitting on a chair. For TUG-cognitive, the individual will be instructed to count backwards by 3 from a random number between 20 and 100 while completing the TUG. The number will be given immediately after the researcher says "go", and errors in subtraction will not be corrected. In TUG-manual, the individual will be asked to pick up and carry a glass full of beans without spilling while completing the TUG. The glass will be placed on a solid surface 90° to the right of the individual while they are sitting, and they will be asked to put the glass back in the same spot before sitting down again.
Assessment of Functional Exercise Capacity
时间窗: At baseline and after 12 weeks of exercise training
A 6-minute walk test (6 MWT) will be used to assess functional exercise capacity. Participants will be asked to walk as fast as possible on a 30-meter straight corridor in the 6 MWT and the distance covered will be recorded in meters. During 6 MWT, walking distance, speed and cadence will be assessed using a wireless motion detection device (G-Walk, BTS Bioengineering SpA, Italy) attached to the individual's waist using a semi-elastic belt over L4-L5.
Assessment of Gait Parameters
时间窗: At baseline and after 12 weeks of exercise training
Individuals will be asked to walk as naturally as possible along an 8-meter path at a speed of their own choosing to assess the time-distance parameters of walking. The 8-meter walk test will measure the time-distance parameters of gait, including step length, stance and swing phases, single support and double support phases. During 8-meter walk test, walking distance, speed, cadence and time-distance parameters of gait will be assessed using a wireless motion detection device (G-Walk, BTS Bioengineering SpA, Italy) attached to the individual's waist using a semi-elastic belt over L4-L5.
次要结局
- Performance Assessment(At baseline and after 12 weeks of exercise training)
- Evaluation of Symptoms(At baseline and after 12 weeks of exercise training)
- Frailty Assessment(At baseline and after 12 weeks of exercise training)
- Assessment of Cancer-Related Fatigue(At baseline and after 12 weeks of exercise training)
- Assessment of Quality of Life(At baseline and after 12 weeks of exercise training)
研究者
Ezgi Ergin
Faculty of Physical Therapy and Rehabilitation, School of Health Sciences, Dokuz Eylul University, Izmir, Turkey
Dokuz Eylul University